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Important Safety InformationENTERRA THERAPY

Medtronic Enterra™ Therapy for Gastroparesis: Patient should always discuss the potential risks and benefits of the device with the physician.

Indications for Use

The Enterra Therapy System for gastric electrical stimulation is indicated for use in the treatment of chronic, intractable (drug refractory) nausea and vomiting associated with gastroparesis caused by diabetes or an unknown origin in patients aged 18 to 70 years.

Contraindications

The Enterra Therapy System is not intended for patients whom the physician determines are not candidates for surgical procedures and/or anesthesia due to physical or mental health conditions. You cannot have diathermy (deep heat treatment from electromagnetic energy) if you have an Enterra device. Patients should not have magnetic resonance imaging (MRI).

Warnings/Precautions/Adverse Events

This system has not been evaluated for pregnant women, for use in patients under the age of 18, or patients over the age of 70. The system may be affected by or adversely affect cardiac devices. Strong sources of electromagnetic interference (EMI) such as from electrocautery, defibrillation/cardioversion, therapeutic ultrasound, radiofrequency (RF)/microwave ablation, or MRI, can result in serious injury, system damage, or operational changes to the system. EMI, postural changes, or other activities may cause shocking or jolting sensations. Patients on anticoagulation therapy may be at a greater risk for post-operative complications. The use of non-Medtronic components with this system may result in damage to Medtronic components, loss of therapy, or patient injury. There is the possibility of an allergic or immune system response to the implanted materials. When possible, a physician is to identify and treat any infections prior to surgery. Infections at the implant site almost always require the surgical removal of the implanted system. The lead can become entangled with the bowel or perforate your stomach and cause life-threatening blockage or infections that require immediate medical attention, and may require surgery.

Patients should avoid activities that may put undue stress on the implanted system components (activities that include sudden, excessive, or repetitive bending, twisting, bouncing, or stretching that can cause component fracture or dislodgment).

Adverse events related to the therapy, device, or procedure can include: infection, pain at the surgery site, device components may wear through the skin, bruising at the neurostimulator site, bleeding, loss of therapeutic effect, undesirable change in stimulation (described as a jolting, shocking, or burning sensation), gastrointestinal symptoms and gastrointestinal complications (in that the lead may perforate your stomach or device components may become entangled with or obstruct other internal organs, requiring surgery). The system could stop because of battery depletion or mechanical or electrical problems. Any of these situations may require additional surgery or cause your symptoms to return.

Humanitarian Device

Authorized by Federal law for use in the treatment of chronic, intractable (drug refractory) nausea and vomiting associated with gastroparesis caused by diabetes or an unknown origin in patients aged 18 to 70 years. The effectiveness of this device for this use has not been demonstrated.